Lori M Laffel, Timothy S Bailey, Mark P Christiansen, Jennifer L Reid, Stayce E Beck
Journal: Journal of diabetes science and technology 2023;17(4):962-967
PMID: 35466707
Continuous glucose monitoring (CGM) systems are approved in many countries to inform diabetes treatment decisions in children 2 years and older. The CGM technology has helped children and adolescents with type 1 diabetes (T1D) improve their glycaemic control, and studies have demonstrated the importance of early CGM initiation and frequent sensor usage on glycaemic outcomes. This study's aim was to assess the performance of the G7 CGM system [the performance of a seventh-generation is a disposable, single-use device]. This study was a prospective, multicentre, single-arm study. Participants were enrolled at six US clinical sites and included older (ages 7-17 years) and younger (ages 2-6) cohorts. Results showed that: - For participants aged 7 to 17, the G7 CGM showed good accuracy with mean absolute relative difference of 8.1% for arm-placed sensors and 9.0% for abdomen-placed sensors. - Accuracy was maintained across wear days, glucose ranges, and rates of glucose change. - Among children aged 2 to 6, the overall mean absolute relative difference was 9.3%. Authors concluded the G7 CGM system provided accurate glucose concentration estimates in children and adolescents with T1D, whether placed on the abdomen or arm. Their findings may help alleviate fear of hypoglycaemia and improve quality of life for this population.
BACKGROUND
Accuracy of a seventh-generation "G7" continuous glucose monitoring (CGM) system was evaluated in children and adolescents with type 1 diabetes (T1D).
METHODS
Sensors were worn on the upper arm and abdomen. The CGM data were available from 127 of 132 participants, ages 7 to 17 years, across 10.5 days of use, various glucose concentration ranges, and various rates of glucose change for comparisons with temporally matched venous blood glucose measurements (YSI). Data were also available from 28 of 32 participants, ages 2 to 6 years, for whom capillary (fingerstick) blood provided comparator glucose values. Accuracy metrics included the mean absolute relative difference (MARD) between CGM and comparator glucose pairs, the proportion of CGM values within 15 mg/dL or 15% of comparator values <100 or ≥100 mg/dL, respectively, and the analogous %20/20 and %30/30 agreement rates.
RESULTS
For participants aged 7 to 17, a total of 15 437 matched pairs were obtained from 122 arm-placed and 118 abdomen-placed sensors. For arm-placed sensors, the overall MARD was 8.1% and overall %15/15, %20/20, and %30/30 agreement rates were 88.8%, 95.3%, and 98.7%, respectively. For abdomen-placed sensors, the overall MARD was 9.0% and overall %15/15, %20/20, and %30/30 agreement rates were 86.0%, 92.9%, and 97.7%, respectively. Good accuracy was maintained across wear days, glucose ranges, and rates of glucose change. Among those aged 2 to 6, a total of 343 matched pairs provided an overall MARD of 9.3% and an overall %20/20 agreement rate of 91.5%.
CONCLUSIONS
The G7 CGM placed on the arm or abdomen was accurate in children and adolescents with T1D. NCT#: NCT04794478.
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